Evaluation of the Efficacy and Tolerance of Low Doses of Ethosuximide in the Treatment of Peripheral Neuropathic Pain

Last updated: January 5, 2023
Sponsor: University Hospital, Clermont-Ferrand
Overall Status: Active - Recruiting

Phase

2

Condition

Pain

Pain (Pediatric)

Treatment

N/A

Clinical Study ID

NCT04431778
PHRC-IR 2019 DELAGE
  • Ages > 18
  • All Genders

Study Summary

Evaluation of the efficacy and tolerance of low doses of ethosuximide in the treatment of peripheral neuropathic pain

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female (under effective contraception: pill, implant, IUD, sterilization) aged 18 years or older, suffering from peripheral neuropathic pain (DN4 ≥ 4) for more than 3 months, of intensity ≥ 4 on a numerical scale from 0 to 10, and whose analgesictreatment has been stable for more than a month,
  • Patients affiliated to the French Social Security system,
  • Patients whose free and informed consent has been obtained.

Exclusion

Exclusion Criteria:

  • Pregnancy (βHCG+ blood) or breastfeeding,
  • Neuropathic pain due to spinal cord or brain injury, phantom limb pain oralgohallucinosis,
  • Fibromyalgia or algodystrophy,
  • Chronic pain syndrome that the patient cannot distinguish and/or is more intense thanperipheral neuropathic pain,
  • Significant abnormalities in liver (transaminases > 3N, cholestasis) and renal (MDRD < 60 mL/min) tests,
  • Ongoing comorbidities: cancer, neurodegenerative pathology
  • Severe depressive disorder in progress (as determined by the clinician), history ofsuicide attempts or hospitalization for depression,
  • Diabetic patients (contraindicated due to the high sugar concentration ofethosuximide, 3g / 5 ml),
  • Patients who have previously received ethosuximide (epilepsy or clinical trial),
  • Surgery planned throughout the entire trial,
  • Medical and surgical history incompatible with the study,
  • Dependence on alcohol and/or drugs (for compliance purposes),
  • Known allergy to succinimides (ethosuximide, methsuximide, phensuximide),
  • Psychotic disorders,
  • Epileptic patients,
  • Patients benefiting from a legal protection measure (curatorship, guardianship,deprived of liberty or subject to judicial safeguard).

Study Design

Total Participants: 64
Study Start date:
November 01, 2020
Estimated Completion Date:
December 31, 2023

Study Description

Multicenter, randomized, double-blind, placebo-controlled therapeutic trial evaluating the efficacy and safety of low doses of ethosuximide in neuropathic pain patients.

Connect with a study center

  • University Hospital Lyon sud - Pierre Bénite

    Lyon, Aura 69310
    France

    Site Not Available

  • Uniervity hospital, Amiens

    Amiens, 80000
    France

    Site Not Available

  • Hospital of Annecy Genevois

    Annecy,
    France

    Site Not Available

  • CIC, Hospital University, Clermont Ferrand

    Clermont-Ferrand,
    France

    Site Not Available

  • University hospital, clermont ferrand

    Clermont-Ferrand, 63000
    France

    Active - Recruiting

  • University Hospital, Grenoble

    Grenoble,
    France

    Site Not Available

  • CHu Limoges

    Limoges,
    France

    Site Not Available

  • Hospital University, Lyon

    Lyon,
    France

    Site Not Available

  • University Hospital, Saint Etienne

    Saint-Étienne,
    France

    Site Not Available

  • Hospital of Valence

    Valence,
    France

    Site Not Available

  • Hospital of Vienne

    Vienne,
    France

    Site Not Available

  • Hospital of Voiron

    Voiron,
    France

    Site Not Available

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